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Not yet recruiting NCT07488845

Management of Vascular Complications in Pediatric Supracondylar Humerus Fractures

No phase Interventional Vascular Complications Supracondylar Humerus Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: vascular exploration.
Who it may be relevant to
Registry conditions: Vascular Complications, Supracondylar Humerus Fracture. Basic parameters: up to 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

* To determine the incidence and types of vascular injuries associated with pediatric supracondylar humerus fractures. * Identify outcomes of different management strategies * Identify risk factors for vascular injury

Detailed description

Supracondylar humerus fractures are the most common elbow fractures in children. Because the brachial artery lies anterior to the distal humerus, displaced fractures can cause:

Arterial spasm, Intimal injury, Thrombosis, Entrapment or transection) Vascular injury risk increases significantly with higher Gartland classifications of supracondylar humerus fractures, peaking in Type III and Type IV injuries.

Vascular compromise can lead to ischemia, compartment syndrome, and long-term functional deficits if not promptly identified and treated.

The decision-making around "pink pulseless hand" remains controversial Some centers advocate observation after reduction, while others recommend early exploration.

Interventions

  • Procedure vascular exploration
    Patients with no pulse or distal doppler signals, and delayed capillary refill time will undergo immediate vascular exploration and injuries will be documented and managed accordingly.

Primary outcome measures

  • incidence of vascular complications in patients with supracondylar humerus fractures [Time frame: baseline]
Secondary outcome measures (1)
  • Predictors of vascular complications in pediatric supracondylar humerus fractures. [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • ● Children Diagnosed with supracondylar humerus fracture (Gartland I-IV) aged under 15 years.
  • Presented within 1st 48 hrs of injury.

Exclusion criteria

  • ● Old trauma >48 hours
  • Previous vascular intervention in the same limb
  • Another fracture in the same limb

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Factorial
Masking
Open label
Primary purpose
Screening

Study locations

Egypt · 1 center
  • Assiut University — Asyut

Publications

  • Dabis J, Daly K, Gelfer Y (2016): Supracondylar fractures of the humerus in children: a review of management and controversies. Orthopedic & Muscular System, 5(01): 1-4.
  • Benedetti Valentini M, Farsetti P, Martinelli O, Laurito A, Ippolito E. The value of ultrasonic diagnosis in the management of vascular complications of supracondylar fractures of the humerus in children. Bone Joint J. 2013 May;95-B(5):694-8. doi: 10.1302/0301-620X.95B5.31042. PMID 23632684
  • Schoenecker PL, Delgado E, Rotman M, Sicard GA, Capelli AM. Pulseless arm in association with totally displaced supracondylar fracture. J Orthop Trauma. 1996;10(6):410-5. doi: 10.1097/00005131-199608000-00008. PMID 8854319
  • Farnsworth CL, Silva PD, Mubarak SJ. Etiology of supracondylar humerus fractures. J Pediatr Orthop. 1998 Jan-Feb;18(1):38-42. PMID 9449099
  • Barr LV. Paediatric supracondylar humeral fractures: epidemiology, mechanisms and incidence during school holidays. J Child Orthop. 2014 Mar;8(2):167-70. doi: 10.1007/s11832-014-0577-0. Epub 2014 Mar 19. PMID 24643672
  • Cheng JC, Lam TP, Maffulli N. Epidemiological features of supracondylar fractures of the humerus in Chinese children. J Pediatr Orthop B. 2001 Jan;10(1):63-7. PMID 11269814
  • Leiblein M, Lustenberger T, Schulz AK, Schmitz-Rixen T, Marzi I. Neurovascular complications after supracondylar humerus fractures in children. Trauma Case Rep. 2017 Jan 6;8:16-19. doi: 10.1016/j.tcr.2017.01.013. eCollection 2017 Apr. PMID 29644308
  • . Hosam Roshdy M, Khaled El Alfy M, Hesham Sharaf M et al. (2016): Vascular Complications of Supracondylar Humeral Fractures in Pediatrics. Egyptian Journal of Vascular and Endovascular Surgery, 12: 1-5

Identifiers

NCT: NCT07488845 · supracodylar humerus fractures

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗